AB1306 HOW DOES COVID-19 VACCINATION AFFECT DISEASE ACTIVITY AND SAFETY IN SECUKINUMAB TREATED PATIENTS WITH AXIAL SPONDYLOARTHRITIS? REAL WORLD DATA FROM THE GERMAN AQUILA STUDY
Authors: J. Brandt-Juergens, K. Gente, P. Kästner, D. Peterlik, U. Kiltz
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Patients (pts) suffering from a chronic rheumatic condition, such as axial spondyloarthritis (axSpA), and receiving immunosuppressive treatment during the COVID-19 pandemic have been shown to be at higher risk of severe disease outcomes. The German non-interventional study AQUILA provides real-world data in pts with axSpA under secukinumab (SEC) treatment and the influence of COVID-19 vaccination on disease activity (DA) and safety [1]. <h3>Objectives</h3> The aim of this interim analysis was to describe selected baseline (BL) characteristics and the effect of vaccination on DA and safety in axSpA pts. <h3>Methods</h3> AQUILA is an ongoing, multi-center study including up to 3000 pts with axSpA or psoriatic arthritis. This analysis focuses on axSpA pts included from May 2019 to Oct 2022 and their vaccination status (no vs ≥1 vaccination) for study time points from BL up to week (w) 52 according to clinical routine. DA was assessed by validated Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questionnaire and safety by documented number of (serious) adverse events (S)AEs). Only pts with available BL BASDAI were considered and characterized by selected BL parameters, such as demographics and global functioning (measured by assessment of spondyloarthritis international society health Index, ASAS-HI). Real-world data were analyzed as observed. Vaccination was performed according to prescription and took place at any timepoint throughout observational period of 52 weeks. <h3>Results</h3> Totally, 273 axSpA pts were included. For 56 pts ≥1 vaccination during study was documented: number of vaccinations (75% mRNA-based): n1 = 26 pts, n2 = 20 pts, n3 = 9 pts, n4 = 1 pt. Both pts groups were comparable regarding the BL characteristics, such as age, smoking status, BMI, physician global assessment (PhGA), and ASAS-HI. Pts with no vaccination received less pretreatments with biologics (59.9% vs 76.8%) and were less affected by comorbidities and extra-articular manifestations (EAMs) than pts with ≥1 vaccination (e.g. depression 6.5% vs 12.5%) (Table 1). There was no difference in mean BASDAI between pts with no and with ≥1 vaccination throughout observational period of 52 weeks (except for a higher mean value in pts with ≥1 vaccination at w16). In both groups, slight improvement was observed in mean BASDAI over time (no vaccination: 5.1 to 3.8, ≥1 vaccination: 5.4 to 3.7) (Figure 1). However, due to different numbers of pts with no and ≥1 vaccination, data must be interpreted carefully. The number of pts with AEs and AEs leading to interruption of SEC was lower in pts with no vs pts with ≥1 vaccination (62.7% vs 75.0% and 13.4% vs 17.9%, respectively) (Table 1), with no new and unexpected safety signals in each group. <h3>Conclusion</h3> In a real-world setting, no differences in DA between axSpA pts with and without vaccination were observed. DA improved similarly up to w52 in both patient groups with similar BL characteristics, though more comorbidities/EAMs were documented in pts with ≥1 vaccination. There were no new safety signals in both groups. Further progress of the AQUILA study will reveal whether this trend will be confirmed with more patients included. <h3>Reference</h3> [1]Deodhar A, et al., ACR Poster (#1776), Arthritis Rheumatol 2022; 74 (suppl 9) <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> Jan Brandt-Juergens Consultant of: Abbvie, Affibody, BMS, Gilead, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Karolina Gente Speakers bureau: AbbVie, BMS, Gilead/Galapagos, Hexal/Sandoz, Janssen, Lilly, Medac, MSD, Novartis, Viatris, Consultant of: BMS, Gilead/Galapagos, Novartis, Grant/research support from: AbbVie, Mundipharma, Novartis, UCB, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Uta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Prizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MDS, Novartis, Pfizer, Roche, USB.